NCT07371338 Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of IPS101A in Parkinson's Disease Patients
| NCT ID | NCT07371338 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Innopeutics Corporation |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2026-05-13 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 6 participants in total. It began in 2026-05-13 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the dose-related safety and tolerability of IPS101A, an adeno-associated virus (AAV) gene therapy, in patients with Parkinson's disease who exhibit severe functional impairment corresponding to Hoehn \& Yahr stages 4-5 and whose symptoms are not adequately controlled despite all available monotherapy and combination therapy options. In addition, the study aims to assess the maximum tolerated dose (MTD) of IPS101A, as well as its preliminary efficacy and pharmacokinetic (PK) characteristics.
Eligibility Criteria
Inclusion Criteria: 1. Subjects who have a diagnosis of Parkinson's disease that meets the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria at the time of the Screening Visit. 2. Male or female subjects aged 50 to 80 years (inclusive) at the time of providing written informed consent, with a documented diagnosis of Parkinson's disease. 3. Subjects with a duration of Parkinson's disease of at least 10 years prior to the Screening Visit, based on medical history and/or medical records. 4. Subjects with Parkinson's disease that is inadequately controlled despite all available standard-of-care treatments, including monotherapy or combination therapy, as determined by the Investigator. 5. Subjects with a Hoehn \& Yahr stage of 4 or 5 in the off state at the Screening Visit. Exclusion Criteria: 1. Subjects with Parkinson's disease dementia (PDD) who meet the diagnostic criteria established by the Movement Disorder Society (MDS) Task Force, as determined by the Investigator at Screening. 2. Subjects with a Korean Mini-Mental State Examination (K-MMSE) score ≤ 24 at the Screening assessment. 3. Subjects in whom imaging findings suggestive of Parkinsonism-plus syndrome are observed on PET and MRI performed at the Screening Visit, as assessed by the Investigator and/or a qualified imaging specialist. 4. Subjects who do not meet the diagnostic criteria for Parkinson's disease dementia but present with major visual hallucinations, as judged by the Investigator. 5. Subjects with drug-induced parkinsonism, confirmed by clinical history and/or medical records, and determined by the Investigator. 6. Subjects who are judged by the investigator to be unsuitable for participation in this clinical trial.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07371338 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07371338 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07371338 currently recruiting?
Yes, NCT07371338 is actively recruiting participants. Contact the research team at clpark@innopeutics.com for enrollment information.
Where is the NCT07371338 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07371338 clinical trial?
NCT07371338 is sponsored by Innopeutics Corporation. The trial plans to enroll 6 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.